|
1
|
Schpero WL, Takvorian SU, Blickstein D, Shafquat A, Liu J, Chatterjee AK, Lamont EB, Chatterjee P. Association Between State Medicaid Policies and Accrual of Black or Hispanic Patients to Cancer Clinical Trials. J Clin Oncol 2024; 42:3238-3246. [PMID: 39052944 PMCID: PMC11408099 DOI: 10.1200/jco.23.01149] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2023] [Revised: 04/14/2024] [Accepted: 05/10/2024] [Indexed: 07/27/2024] Open
Abstract
PURPOSE It is unknown whether Medicaid expansion under the Affordable Care Act (ACA) or state-level policies mandating Medicaid coverage of the routine costs of clinical trial participation have ameliorated longstanding racial and ethnic disparities in cancer clinical trial enrollment. METHODS We conducted a retrospective, cross-sectional difference-in-differences analysis examining the effect of Medicaid expansion on rates of enrollment for Black or Hispanic nonelderly adults in nonobservational, US cancer clinical trials using data from Medidata's Rave platform for 2012-2019. We examined heterogeneity in this effect on the basis of whether states had pre-existing mandates requiring Medicaid coverage of the routine costs of clinical trial participation. RESULTS The study included 47,870 participants across 1,353 clinical trials and 344 clinical trial sites. In expansion states, the proportion of participants who were Black or Hispanic increased from 16.7% before expansion to 17.2% after Medicaid expansion (0.5 percentage point [PP] change [95% CI, -1.1 to 2.0]). In nonexpansion states, this proportion increased from 19.8% before 2014 (when the first states expanded eligibility under the ACA) to 20.4% after 2014 (0.6 PP change [95% CI, -2.3 to 3.5]). These trends yielded a nonsignificant difference-in-differences estimate of 0.9 PP (95% CI, -2.6 to 4.4). Medicaid expansion was associated with a 5.3 PP (95% CI, 1.9 to 8.7) increase in the enrollment of Black or Hispanic participants in states with mandates requiring Medicaid coverage of the routine costs of trial participation, but not in states without mandates (-0.3 PP [95% CI, -4.5 to 3.9]). CONCLUSION Medicaid expansion was not associated with a significant increase in the proportion of Black or Hispanic oncology trial participants overall, but was associated with an increase specifically in states that mandated Medicaid coverage of the routine costs of trial participation.
Collapse
Affiliation(s)
- William L. Schpero
- Division of Health Policy and Economics, Department of Population Health Sciences, Weill Medical College; and Center for Health Equity, Cornell University, New York, NY
| | - Samuel U. Takvorian
- Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
- Department of Medicine, Perelman School of Medicine; and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
| | | | | | - Jingshu Liu
- Medidata AI, a Dassault Systèmes Company, New York, NY
| | | | | | - Paula Chatterjee
- Department of Medicine, Perelman School of Medicine; and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
| |
Collapse
|
|
2
|
Joyce DD, Wymer KM, Sharma V, Moriarty JP, Borah BJ, Geynisman DM, Plimack ER, Costello BA, Pagliaro LC, Boorjian SA. Comparative cost-effectiveness of neoadjuvant chemotherapy regimens for muscle-invasive bladder cancer: Results according to VESPER data. Cancer 2022; 128:4194-4202. [PMID: 36251574 DOI: 10.1002/cncr.34502] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2022] [Revised: 08/16/2022] [Accepted: 08/30/2022] [Indexed: 01/31/2023]
Abstract
BACKGROUND The VESPER trial demonstrated improved progression-free (PFS) and (preliminarily) overall survival (OS) with six cycles of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVACx6) versus four cycles of gemcitabine and cisplatin (GCx4) before radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC), but with increased toxicity. This study compares the cost-effectiveness of these regimens. METHODS A cost-effectiveness analysis of neoadjuvant ddMVACx6 and GCx4 was performed using a decision-analytic Markov model with 5-year, 10-year, and lifetime horizons. Probabilities were derived from reported VESPER data. Utility values were obtained from the literature. Primary outcomes were effectiveness measured in quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER) with a willingness to pay threshold of $100,000 per QALY. One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the model. RESULTS At 5 years, ddMVACx6 improved QALYs by 0.30 at an additional cost of $16,100, rendering it cost-effective relative to GCx4 (ICER: $53,284/QALY). Additionally, probabilistic sensitivity analysis found ddMVACx6 to be cost-effective in 79% and 81% of microsimulations at10-year and lifetime horizons, respectively. One-way sensitivity analysis demonstrated a minimum difference in 5-year progression of 0.9% and progression mortality of 0.7% between ddMVACx6 and GCx4 was necessary for ddMVACx6 to remain cost-effective. CONCLUSIONS Neoadjuvant ddMVACx6 was more cost-effective than GCx4 for MIBC. These data, together with the improved PFS and (albeit preliminary) OS noted in VESPER, support use of this regimen in appropriate candidates for neoadjuvant chemotherapy before RC. LAY SUMMARY We performed a benefit-to-cost analysis using evidence from a randomized controlled trial that compared two different chemotherapy treatments before bladder removal for bladder cancer that had invaded into the bladder muscle. Despite being more expensive and having a greater likelihood of toxicity, six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin was more cost-effective (or had higher value) than four cycles of gemcitabine and cisplatin.
Collapse
Affiliation(s)
- Daniel D Joyce
- Department of Urology, Mayo Clinic, Rochester, Minnesota, USA
| | - Kevin M Wymer
- Department of Urology, Mayo Clinic, Rochester, Minnesota, USA
| | - Vidit Sharma
- Department of Urology, Mayo Clinic, Rochester, Minnesota, USA
| | - James P Moriarty
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA
| | - Bijan J Borah
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA
| | - Daniel M Geynisman
- Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA
| | - Elizabeth R Plimack
- Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA
| | | | | | | |
Collapse
|
|
3
|
Le-Rademacher J, Mohile S, Unger J, Hudson MF, Foster J, Lichtman S, Perlmutter J, Dotan E, Extermann M, Dodd K, Tew W, Klepin H, Wildes TM, Sedrak MS, Jatoi A, Little RF. Trial Design Considerations to Increase Older Adult Accrual to National Cancer Institute Clinical Trials. J Natl Cancer Inst Monogr 2022; 2022:135-141. [PMID: 36519818 PMCID: PMC9949574 DOI: 10.1093/jncimonographs/lgac023] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2022] [Revised: 08/19/2022] [Accepted: 09/26/2022] [Indexed: 12/23/2022] Open
Abstract
Although adults aged 65 years or older make up a strong majority of cancer patients, their underrepresentation in cancer clinical trials leads to the lack of representative data to guide evidence-based therapeutic decisions in this patient population. The Trial Design Working Group, convened as part of the workshop titled, Engaging Older Adults in the National Cancer Institute Clinical Trials Network: Challenges and Opportunities, recommended study designs and design elements that could improve accrual of older adults in National Cancer Institute-funded clinical trials. These include trials that are specifically designed to enroll older adults, trials that include a cohort of older patients (parallel cohort, stratified cohort, or embedded cohort), and trials with pragmatic design elements to facilitate enrollment of older adults. This manuscript provides brief descriptions of the recommended designs, examples of successful trials, and considerations for implementation of these designs. As with any clinical trial, the scientific questions and trial objectives should drive the study design, the selection of endpoints and intervention, and eligibility criteria. When designing trials that include older adults, the heterogeneity of fitness levels is an important consideration as fitness can influence accrual rates and outcomes. Appropriately incorporating geriatric assessments can help identify the optimal subset of older patients for inclusion and minimize selection bias. Incorporating pragmatic design elements to reduce the burden on trial participants as well as on accruing sites and retaining essential elements to ensure that the main goal of the trial can be accomplished can enhance enrollment without compromising the integrity of trials.
Collapse
Affiliation(s)
| | - Supriya Mohile
- Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA
| | - Joseph Unger
- Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
| | | | - Jared Foster
- Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD, USA
| | | | | | - Efrat Dotan
- Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA
| | | | - Kevin Dodd
- Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA
| | - William Tew
- Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Heidi Klepin
- Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA
| | | | - Mina S Sedrak
- Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, CA, USA
| | - Aminah Jatoi
- Department of Oncology, Mayo Clinic, Rochester, MN, USA
| | - Richard F Little
- Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD, USA
| |
Collapse
|
|
4
|
Akushevich I, Yashkin A, Kovtun M, Yashin AI, Kravchenko J. Underlying mechanisms of change in cancer prevalence in older U.S. adults: contributions of incidence, survival, and ascertainment at early stages. Cancer Causes Control 2022; 33:1161-1172. [PMID: 35799033 PMCID: PMC9360135 DOI: 10.1007/s10552-022-01595-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2022] [Accepted: 06/07/2022] [Indexed: 12/02/2022]
Abstract
PURPOSE To quantitatively evaluate contributions of trends in incidence, relative survival, and stage at diagnosis to the dynamics in the prevalence of major cancers (lung, prostate, colon, breast, urinary bladder, ovaries, stomach, pancreas, esophagus, kidney, liver, and skin melanoma) among older U.S. adults age 65 +. METHODS Trend partitioning was applied to the Surveillance, Epidemiology, and End Results Program data for 1973-2016. RESULTS Growth of cancer prevalence in older adults decelerated or even decreased over time for all studied cancers due to decreasing incidence and improving survival for most of cancers, with a smaller contribution of the stage at cancer diagnosis. Changes in the prevalence of cancers of the lung, colon, stomach, and breast were predominantly due to decreasing incidence, increasing survival and more frequent diagnoses at earlier stages. Changes in prevalence of some other cancers demonstrated adverse trends such as decreasing survival in localized and regional stages (urinary bladder and ovarian) and growing impact of late-stage diagnoses (esophageal cancer). CONCLUSION While decelerating or decreasing prevalence of many cancers were due to a beneficial combination of decreasing incidence and increasing survival, there are cancers for which decelerating prevalence is due to lack of improvement in their stage-specific survival and/or increasing frequency of diagnosis at advanced stages. Overall, if the observed trends persist, it is likely that the burden associated with cancer prevalence in older U.S. adults will be lower comparing to projections based on constant increasing prevalence have previously estimated.
Collapse
Affiliation(s)
- I Akushevich
- Center for Population Health and Aging, Duke University, Durham, NC, USA.
| | - A Yashkin
- Center for Population Health and Aging, Duke University, Durham, NC, USA
| | - M Kovtun
- Center for Population Health and Aging, Duke University, Durham, NC, USA
| | - A I Yashin
- Center for Population Health and Aging, Duke University, Durham, NC, USA
| | - J Kravchenko
- Department of Surgery, Duke University School of Medicine, Duke University, Durham, NC, USA
| |
Collapse
|
|
5
|
Green AK, Tabatabai SM, Bai X, Mishra Meza A, Lesny AM, Aghajanian C, Landgren O, Riely GJ, Sabbatini P, Salner A, Lipkin S, Ip A, Bach PB, Begg CB, Mailankody S, Lipitz-Snyderman A. Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation. JAMA Netw Open 2022; 5:e223687. [PMID: 35315914 PMCID: PMC8941352 DOI: 10.1001/jamanetworkopen.2022.3687] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Abstract
IMPORTANCE The Centers for Medicare & Medicaid Services requires health care organizations to report the National Clinical Trial (NCT) identifier on claims for items and services related to clinical trials that qualify for coverage. This same NCT identifier is used to identify clinical trials in the ClinicalTrials.gov registry. If linked, this information could facilitate population-based analyses of clinical trial participation and outcomes. OBJECTIVE To evaluate the validity of a linkage between fee-for-service (FFS) Medicare claims and ClinicalTrials.gov through the NCT identifier for patients with cancer enrolled in clinical trials. DESIGN, SETTING, AND PARTICIPANTS This cohort study included 2 complementary retrospective analyses for a validation assessment. First, billing data from 3 health care institutions were used to estimate the missingness of the NCT identifier in claims by calculating the proportion of known participants in cancer clinical trials with no NCT identifier on any submitted Medicare claims. Second, the Surveillance Epidemiology and End Results-Medicare data set, which includes a subset of all FFS Medicare beneficiaries for whom health insurance claims are linked with cancer registry data, was used to identify adult patients diagnosed with cancer between 2006 and 2015 with an NCT identifier in claims corresponding to an interventional cancer clinical trial. To estimate the accuracy of the NCT identifier when present, the proportion of NCT identifiers that corresponded to trials that were aligned with the patients' known primary or secondary diagnoses was calculated. Data were analyzed from March 2020 to March 2021. EXPOSURES An NCT identifier present in Medicare claims. MAIN OUTCOMES AND MEASURES The main outcome was participating in a clinical trial relevant to patient's cancer diagnosis. RESULTS A total of 1 171 816 patients were included in analyses. Across the 3 participating institutions, there were 5061 Medicare patients enrolled in a clinical trial, including 3797 patients (75.0%) with an NCT identifier on at least 1 billing claim that matched the clinical trial on which the patient was participating. Among 1 171 816 SEER-Medicare patients, 29 138 patients (2.5%) had at least 1 claim with a value entered in the NCT identifier field corresponding to 32 950 unique patient-NCT identifier pairs. There were 26 694 pairs (81.0%) with an NCT identifier corresponding to a clinical trial registered in ClinicalTrials.gov, of which 10 170 pairs (38.1%) were interventional cancer clinical trials. Among these, 9805 pairs (96.4%) were considered appropriate. CONCLUSIONS AND RELEVANCE In this cohort study, this data linkage provided a novel data source to study clinical trial enrollment patterns among Medicare patients with cancer on a population level. The presence of the NCT identifiers in claims for Medicare patients participating in clinical trials is likely to improve over time with increasing adherence with the Centers for Medicare & Medicaid Services mandate.
Collapse
Affiliation(s)
- Angela K. Green
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Sara M. Tabatabai
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Xing Bai
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Akriti Mishra Meza
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Anne-Marie Lesny
- Patient Revenue Support, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Carol Aghajanian
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Ola Landgren
- Myeloma Program, Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida
| | - Gregory J. Riely
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Paul Sabbatini
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Andrew Salner
- Hartford Healthcare Cancer Institute, Hartford Hospital, Hartford, Connecticut
| | - Scott Lipkin
- Miami Cancer Institute, Baptist Health South Florida, Miami
| | - Andrew Ip
- Division of Outcomes and Value Research, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey
- Hackensack Meridian School of Medicine, Nutley, New Jersey
| | - Peter B. Bach
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Colin B. Begg
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Sham Mailankody
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Allison Lipitz-Snyderman
- Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
| |
Collapse
|
|
6
|
Shankaran V, Unger JM, Darke AK, Suga JM, Wade JL, Kourlas PJ, Chandana SR, O’Rourke MA, Satti S, Liggett D, Hershman DL, Ramsey SD. S1417CD: A Prospective Multicenter Cooperative Group-Led Study of Financial Hardship in Metastatic Colorectal Cancer Patients. J Natl Cancer Inst 2022; 114:372-380. [PMID: 34981117 PMCID: PMC8902339 DOI: 10.1093/jnci/djab210] [Citation(s) in RCA: 33] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2021] [Revised: 08/19/2021] [Accepted: 10/15/2021] [Indexed: 01/07/2023] Open
Abstract
BACKGROUND Financial toxicity is a growing problem in oncology, but no prior studies have prospectively measured the financial impact of cancer treatment in a diverse national cohort of newly diagnosed cancer patients. S1417CD was the first cooperative group-led multicenter prospective cohort study to evaluate financial hardship in metastatic colorectal cancer (mCRC) patients. METHODS Patients aged 18 years or older within 120 days of mCRC diagnosis completed quarterly questionnaires for 12 months. We estimated the cumulative incidence of major financial hardship (MFH), defined as 1 or more of increased debt, new loans from family and/or friends, selling or refinancing home, or 20% or more income decline. We evaluated the association between patient characteristics and MFH using multivariate cox regression and the association between MFH and quality of life using linear regression. RESULTS A total of 380 patients (median age = 59.9 years) were enrolled; 77.7% were White, 98.0% insured, and 56.5% had annual income of $50 000 or less. Cumulative incidence of MFH at 12 months was 71.3% (95% confidence interval = 65.7% to 76.1%). Age, race, marital status, and income (split at $50 000 per year) were not statistically significantly associated with MFH. However, income less than $100 000 and total assets less than $100 000 were both associated with greater MFH. MFH at 3 months was associated with decreased social functioning and quality of life at 6 months. CONCLUSIONS Nearly 3 out of 4 mCRC patients experienced MFH despite access to health insurance. These findings underscore the need for clinic and policy solutions that protect cancer patients from financial harm.
Collapse
Affiliation(s)
- Veena Shankaran
- Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA,Division of Medical Oncology, University of Washington School of Medicine, Seattle, WA, USA,Correspondence to: Veena Shankaran, MD, MS, Division of Medical Oncology, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center, University of Washington, 825 Eastlake Ave E, MS LG-465, Seattle, WA 98109, USA (e-mail: )
| | - Joseph M Unger
- SWOG Statistics and Data Management Center, Seattle, WA, USA
| | - Amy K Darke
- SWOG Statistics and Data Management Center, Seattle, WA, USA
| | | | - James L Wade
- Cancer Care Specialists of Illinois/Heartland NCORP, Decatur, IL, USA
| | - Peter J Kourlas
- Columbus Oncology Associates, Columbus/Columbus NCORP, Columbus, OH, USA
| | - Sreenivasa R Chandana
- Cancer and Hematology Centers of Western Michigan/Cancer Research Consortium of West Michigan NCORP, Grand Rapids, MI, USA
| | - Mark A O’Rourke
- Prisma Health Cancer Institute/NCORP of the Carolinas (Prisma Health), Greenville, SC, USA
| | - Suma Satti
- Ochsner Cancer Institute, New Orleans, LA, USA
| | - Diane Liggett
- SWOG Data Operations Center/Cancer Research and Biostatistics (CRAB), Seattle, WA, USA
| | | | - Scott D Ramsey
- Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
| |
Collapse
|
|
7
|
Unger JM, Beauchemin M, Hershman DL. Adolescent and young adult enrollment to a National Cancer Institute-sponsored National Clinical Trials Network Research Group over 25 years. Cancer 2021; 127:4574-4584. [PMID: 34351619 PMCID: PMC8665001 DOI: 10.1002/cncr.33855] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2021] [Revised: 07/21/2021] [Accepted: 07/23/2021] [Indexed: 01/03/2023]
Abstract
BACKGROUND Adolescent and young adult (AYA) patients with cancer have not seen the same improvements in survival as younger (pediatric) patients and older patients (adults 40 years old or older). This may be related to their lower participation in clinical trials. METHODS This study examined AYA patient accrual to SWOG Cancer Research Network phase 1 to 3 clinical treatment trials for 29 cancers over 25 years (January 1996 to December 2020). Trial enrollments for AYA patients (15-39 years old) were compared with trial enrollments for older patients (40 years old or older) in SWOG and with US AYA cancer population rates derived from US Census and National Cancer Institute/Surveillance, Epidemiology, and End Results data. RESULTS In total, 84,219 patients were enrolled in SWOG treatment trials, including 7109 AYA patients (8.4%); in contrast, AYAs constituted 3.8% of the US cancer population. By histology, the highest proportions of AYA patients were in trials for Hodgkin disease (825 of 1220; 67.6%) and acute lymphocytic leukemia (350 of 678; 51.6%), whereas breast cancer trials had the greatest number of AYA patients (3032 of 32,693; 9.3%). SWOG AYA patients were more often female (68.8% vs 58.7%; P < .001), Black (10.1% vs 8.2%; P < .001), and Hispanic (10.6% vs 5.6%; P < .001) than SWOG patients who were 40 years old or older, and they were more often female (68.8% vs 65.1%; P < .001) but less often Black (10.1% vs 11.8%; P < .001) or Hispanic (10.6% vs 12.8%; P < .001) than AYA patients in the US cancer population. CONCLUSIONS AYA patients with cancer were well represented in SWOG clinical trials in comparison with US cancer population patients with the same cancers. The SWOG AYA population was more racially/ethnically diverse than older SWOG patients, although it was less diverse than the US AYA cancer population. LAY SUMMARY Adolescent and young adult (AYA) patients with cancer (aged 15-39 years) have not seen the same improvements in survival as younger (pediatric) patients and older patients (adults 40 years old or older). This may be related to their lower participation in clinical trials. This study evaluated the extent to which AYA patients were enrolled in a large, National Cancer Institute-sponsored network group over 25 years (1996-2020). Overall, 8.4% of the enrolled patients (7109 of 84,219) were AYAs; this was twice the corresponding rate of 3.8% in the US cancer population. AYA patients were also more racially/ethnically diverse than older trial patients, although they were less racially/ethnically diverse than the US AYA cancer population.
Collapse
Affiliation(s)
- Joseph M. Unger
- SWOG Statistics & Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA
| | | | - Dawn L. Hershman
- Columbia University Mailman School of Public Health, New York, NY
| |
Collapse
|
|
8
|
Kearns C, Feighery R, Mc Caffrey J, Higgins M, Smith M, Murphy V, O’Reilly S, Horgan AM, Walshe J, McDermott R, Morris PG, Keane M, Martin M, Murphy C, Duffy K, Mihai A, Armstrong J, O’Donnell DM, Gallagher WM, Kelly CM, Kelly CM. Understanding and Attitudes toward Cancer Clinical Trials among Patients with a Cancer Diagnosis: National Study through Cancer Trials Ireland. Cancers (Basel) 2020; 12:cancers12071921. [PMID: 32708702 PMCID: PMC7409272 DOI: 10.3390/cancers12071921] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2020] [Revised: 07/11/2020] [Accepted: 07/13/2020] [Indexed: 11/16/2022] Open
Abstract
Cancer clinical trials (CCTs) are critical to translation and development of better therapies to improve outcomes. CCTs require adequate patient involvement but accrual rates are low globally. Several known barriers impede participation and knowing how subpopulations differ in understanding of CCTs can foster targeted approaches to aid accrual and advance cancer treatments. We conducted the first nationwide survey of 1089 patients attending 14 Irish cancer centres, assessing understanding of fundamental concepts in CCT methodology and factors that influence participation, to help tailor patient support for accrual to CCTs. Two-thirds (66%) of patients reported never having been offered a CCT and only 5% of those not offered asked to participate. Misunderstanding of clinical equipoise was prevalent. There were differences in understanding of randomisation of treatment by age (p < 0.0001), ethnicity (p = 0.035) and marital status (p = 0.013), and 58% of patients and 61% previous CCT participants thought that their doctor would ensure better treatment in CCTs. Females were slightly more risk averse. Males indicated a greater willingness to participate in novel drug trials (p = 0.001, p = 0.003). The study identified disparities in several demographics; older, widowed, living in provincial small towns and fewer years-educated patients had generally poorer understanding of CCTs, highlighting requirements for targeted support in these groups.
Collapse
Affiliation(s)
- Cathriona Kearns
- UCD Conway Institute Dublin, D04V1W8 Dublin, Ireland;
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Correspondence: (C.K.); (C.M.K.)
| | - Ronan Feighery
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - John Mc Caffrey
- UCD School of Medicine, Mater Misericordiae University Hospital Dublin, D07AX57 Dublin, Ireland; (J.M.C.); (M.H.); (M.S.); (C.M.K.)
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Michaela Higgins
- UCD School of Medicine, Mater Misericordiae University Hospital Dublin, D07AX57 Dublin, Ireland; (J.M.C.); (M.H.); (M.S.); (C.M.K.)
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Martina Smith
- UCD School of Medicine, Mater Misericordiae University Hospital Dublin, D07AX57 Dublin, Ireland; (J.M.C.); (M.H.); (M.S.); (C.M.K.)
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Verena Murphy
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Seamus O’Reilly
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Cork University Hospital, T12DFK4 Cork, Ireland
| | - Anne M. Horgan
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- University Hospital Waterford, X91ER8E Waterford, Ireland
| | - Janice Walshe
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- St. Vincent University Hospital, D04YN63 Dublin, Ireland
| | - Ray McDermott
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Adelaide & Meath Hospital Incorporating the National Children’s Hospital (AMNCH), D24KNE0 Dublin, Ireland
| | - Patrick G. Morris
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Beaumont Hospital, D09A0KH Dublin, Ireland
| | - Maccon Keane
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Galway University Hospital, SW4794 Galway, Ireland
| | - Michael Martin
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Sligo General Hospital, F91H684 Sligo, Ireland
| | - Conleth Murphy
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Bon Secours Hospital, T12DV56 Cork, Ireland
| | - Karen Duffy
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Letterkenny General Hospital, F92FC82 Donegal, Ireland
| | - Alina Mihai
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Beacon Hospital, D18AK68 Dublin, Ireland
| | - John Armstrong
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- St. Luke’s Radiation Oncology Network, St Luke’s Hospital, Rathgar, D06HH36 Dublin, Ireland
| | - Dearbhaile M. O’Donnell
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- St. James’s Hospital, D08W9RT Dublin, Ireland
| | - William M. Gallagher
- UCD Conway Institute Dublin, D04V1W8 Dublin, Ireland;
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Ciara M. Kelly
- UCD School of Medicine, Mater Misericordiae University Hospital Dublin, D07AX57 Dublin, Ireland; (J.M.C.); (M.H.); (M.S.); (C.M.K.)
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
| | - Catherine M. Kelly
- UCD Conway Institute Dublin, D04V1W8 Dublin, Ireland;
- UCD School of Medicine, Mater Misericordiae University Hospital Dublin, D07AX57 Dublin, Ireland; (J.M.C.); (M.H.); (M.S.); (C.M.K.)
- Cancer Trials Ireland, Innovation House, Old Finglas Road, Glasnevin, D11KXN4 Dublin, Ireland; (R.F.); (V.M.); (S.O.); (A.M.H.); (J.W.); (R.M.); (P.G.M.); (M.K.); (M.M.); (C.M.); (K.D.); (A.M.); (J.A.); (D.M.O.)
- Correspondence: (C.K.); (C.M.K.)
| |
Collapse
|
|
9
|
Batra A, Rigo R, Sheka D, Cheung WY. Real-world evidence on adjuvant chemotherapy in older adults with stage II/III colon cancer. World J Gastrointest Oncol 2020; 12:604-618. [PMID: 32699576 PMCID: PMC7340998 DOI: 10.4251/wjgo.v12.i6.604] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/24/2020] [Revised: 05/08/2020] [Accepted: 05/29/2020] [Indexed: 02/06/2023] Open
Abstract
Colon cancer represents one of the most common cancers diagnosed in older adults worldwide. The standard of care in resected stage II and stage III colon cancer continues to evolve. While there is unequivocal evidence to suggest both disease free and overall survival benefits with the use of combination chemotherapy in patients with stage III colon cancer, data regarding its use in patients with stage II colon cancer are less clear. Further, although colon cancer is a disease that affects older adults, there is considerable debate on the value of adjuvant chemotherapy in the aging population. In particular, many older patients are undertreated when compared to their younger counterparts. In this review, we will describe the clinical trials that contributed to the current adjuvant chemotherapy approach in colon cancer, discuss representation of older adults in trials and the specific challenges associated with the management of this sub-population, and highlight the role of comprehensive geriatric assessments. We will also review how real-world evidence complements the data gaps from clinical trials of early stage colon cancer.
Collapse
Affiliation(s)
- Atul Batra
- Department of Medicine, Tom Baker Cancer Centre, Calgary, Alberta T2N 1N4, Canada
| | - Rodrigo Rigo
- Department of Medicine, Tom Baker Cancer Centre, Calgary, Alberta T2N 1N4, Canada
| | - Dropen Sheka
- Department of Medicine, Tom Baker Cancer Centre, Calgary, Alberta T2N 1N4, Canada
| | - Winson Y Cheung
- Department of Oncology, University of Calgary, Calgary, Alberta T2N 4N2, Canada
| |
Collapse
|
|
10
|
Unger JM, Hershman DL, Osarogiagbon RU, Gothwal A, Anand S, Dasari A, Overman M, Loree JM, Raghav K. Representativeness of Black Patients in Cancer Clinical Trials Sponsored by the National Cancer Institute Compared With Pharmaceutical Companies. JNCI Cancer Spectr 2020; 4:pkaa034. [PMID: 32704619 PMCID: PMC7368466 DOI: 10.1093/jncics/pkaa034] [Citation(s) in RCA: 73] [Impact Index Per Article: 14.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023] Open
Abstract
Background Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the National Cancer Institute’s National Clinical Trial’s Network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of Black patients in pharmaceutical company–sponsored cancer clinical trials with NCTN trials and with the US cancer population. Methods We established a large cohort of study publications representing the results of trials that supported new US Food and Drug Administration drug approvals from 2008 to 2018. NCTN trial data were from the SWOG Cancer Research Network. US cancer population rates were estimated using Surveillance, Epidemiology, and End Results survey data. We compared the proportion of Black patients by enrollment year for each cancer type and overall. Tests of proportions were used. All statistical tests were 2-sided. Results A total 358 trials (pharmaceutical company–sponsored trials, 85; SWOG trials, 273) comprised of 93 825 patients (pharmaceutical company–sponsored trials, 46 313; SWOG trials, 47 512) for 15 cancer types were analyzed. Overall, the proportion of Black patients was 2.9% for pharmaceutical company–sponsored trials, 9.0% for SWOG trials, and 12.1% for the US cancer population (P < .001 for each pairwise comparison). These findings were generally consistent across individual cancer types. Conclusions The poor representation of Black patients in pharmaceutical company–sponsored trials supporting new drug applications could result in the use of new drugs with little data about efficacy or side effects in this key population. Moreover, because pharmaceutical company–sponsored trials test the newest available therapies, limited access to these trials represents a disparity in access to potential breakthrough therapies.
Collapse
Affiliation(s)
- Joseph M Unger
- SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
| | | | | | | | - Seerat Anand
- Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA
| | - Arvind Dasari
- Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA
| | - Michael Overman
- Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA
| | | | - Kanwal Raghav
- Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA
| |
Collapse
|
|
11
|
Unger JM, Blanke CD, LeBlanc M, Barlow WE, Vaidya R, Ramsey SD, Hershman DL. Association of Patient Demographic Characteristics and Insurance Status With Survival in Cancer Randomized Clinical Trials With Positive Findings. JAMA Netw Open 2020; 3:e203842. [PMID: 32352530 PMCID: PMC7193331 DOI: 10.1001/jamanetworkopen.2020.3842] [Citation(s) in RCA: 34] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
IMPORTANCE Few new treatments tested in phase 3 cancer randomized clinical trials show an overall survival benefit. Although understanding whether the benefits are consistent among all patient groups is critical for informing guideline care, individual trials are designed to assess the benefits of experimental treatments among all patients and are too small to reliably determine whether treatment benefits apply to demographic or insurance subgroups. OBJECTIVE To systematically examine whether positive treatment effects in cancer randomized clinical trials apply to specific demographic or insurance subgroups. DESIGN, SETTING, AND PARTICIPANTS Cohort study of pooled patient-level data from 10 804 patients in SWOG Cancer Research Network clinical treatment trials reported from 1985 onward with superior overall survival for those receiving experimental treatment. Patients were enrolled from 1984 to 2012. Maximum follow-up was 5 years. MAIN OUTCOMES AND MEASURES Interaction tests were used to assess whether hazard ratios (HRs) for death comparing standard group vs experimental group treatments were associated with age (≥65 vs <65 years), race/ethnicity (minority vs nonminority populations), sex, or insurance status among patients younger than 65 years (Medicaid or no insurance vs private insurance) in multivariable Cox regression frailty models. Progression- or relapse-free survival was also examined. Data analyses were conducted from August 2019 to February 2020. RESULTS In total, 19 trials including 10 804 patients were identified that reported superior overall survival for patients randomized to experimental treatment. Patients were predominantly younger than 65 years (67.3%) and female (66.3%); 11.4% were black patients, and 5.7% were Hispanic patients. There was evidence of added survival benefits associated with receipt of experimental therapy for all groups except for patients with Medicaid or no insurance (HR, 1.23; 95% CI, 0.97-1.56; P = .09) compared with those with private insurance (HR, 1.66; 95% CI, 1.44-1.92; P < .001; P = .03 for interaction). Receipt of experimental treatment was associated with reduced added overall survival benefits in patients 65 years or older (HR, 1.21; 95% CI, 1.11-1.32; P < .001) compared with patients younger than 65 years (HR, 1.41; 95% CI, 1.30-1.53; P < .001; P = .01 for interaction), although both older and younger patients appeared to strongly benefit from receipt of experimental treatment. The progression- or relapse-free survival HRs did not differ by age, sex, or race/ethnicity but differed between patients with Medicaid or no insurance (HR, 1.32; 95% CI, 1.06-1.64; P = .01) vs private insurance (HR, 1.74; 95% CI, 1.54-1.97; P < .001; P = .03 for interaction). CONCLUSIONS AND RELEVANCE Patients with Medicaid or no insurance may have smaller added benefits from experimental therapies compared with standard treatments in clinical trials. A better understanding of the quality of survivorship care that patients with suboptimal insurance receive, including supportive care and posttreatment care, could help establish how external factors may affect outcomes for these patients.
Collapse
Affiliation(s)
- Joseph M. Unger
- SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington
- Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Charles D. Blanke
- SWOG Cancer Research Network Group Chair’s Office, Knight Cancer Institute, Oregon Health & Science University, Portland
| | - Michael LeBlanc
- SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington
- Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - William E. Barlow
- SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington
- Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Riha Vaidya
- SWOG Cancer Research Network Statistics and Data Management Center, Seattle, Washington
- Fred Hutchinson Cancer Research Center, Seattle, Washington
| | | | | |
Collapse
|
|
12
|
Mizutani T, Nakamura K, Fukuda H, Ogawa A, Hamaguchi T, Nagashima F. Geriatric Research Policy: Japan Clinical Oncology Group (JCOG) policy. Jpn J Clin Oncol 2020; 49:901-910. [PMID: 31565730 PMCID: PMC6886463 DOI: 10.1093/jjco/hyz093] [Citation(s) in RCA: 21] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2019] [Revised: 05/24/2019] [Accepted: 06/07/2019] [Indexed: 12/18/2022] Open
Abstract
Due to the rapid aging of Japan’s population, clinical research focusing on older patients with cancer is urgently needed. The Japan Clinical Oncology Group (JCOG) has conducted several such clinical trials, but there has been no formal policy for geriatric research. We have therefore established a JCOG policy for geriatric cancer research. We defined the patient selection policy based on treatment tolerance and chronological age. Older patients are categorized into three conceptual groups: ‘fit patients’ who can undergo the same standard treatment given to younger patients, ‘frail patients’ for whom best supportive or palliative care is indicated and ‘vulnerable patients’ who fall between the fit and frail categories. Unmet needs often exist for vulnerable patients. The policy recommends that study endpoints include not only survival but also other endpoints such as physical and cognitive function because the objective of therapy in older patients is not only extended life expectancy but also maintenance of the patient’s general condition. In this viewpoint, co-primary or composite endpoints that incorporate geriatric assessment in the study design are often applicable. Study design will differ depending on the study population, clinical question, and treatment. Even for older patients, a randomized clinical trial is still the gold standard when the clinical question asks which treatment is better. An observational study of a broader population is applicable for investigating actual conditions of older patients. This JCOG Geriatric Research Policy includes several practical solutions for various issues in geriatric research. We plan to revise this policy periodically to guide future geriatric research.
Collapse
Affiliation(s)
- Tomonori Mizutani
- JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo
| | - Kenichi Nakamura
- JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo
| | - Haruhiko Fukuda
- JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo
| | - Asao Ogawa
- Department of Psycho-Oncology Service, National Cancer Center Hospital East, Chiba
| | - Tetsuya Hamaguchi
- Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama
| | - Fumio Nagashima
- Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo
| | | |
Collapse
|
|
13
|
Obeng-Gyasi S, Kircher SM, Lipking KP, Keele BJ, Benson AB, Wagner LI, Carlos RC. Oncology clinical trials and insurance coverage: An update in a tenuous insurance landscape. Cancer 2019. [PMID: 31251394 DOI: 10.1002/cncr.32360.] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Affiliation(s)
- Samilia Obeng-Gyasi
- Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana
| | - Sheetal M Kircher
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois
| | - Kelsey P Lipking
- Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana
| | - Benjamin J Keele
- Robert H. McKinney School of Law, Indiana University, Indianapolis, Indiana
| | - Al B Benson
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois
| | - Lynne I Wagner
- Social Sciences and Health Policy Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, North Carolina
| | - Ruth C Carlos
- Department of Radiology, University of Michigan School of Medicine, Ann Arbor, Michigan
| |
Collapse
|
|
14
|
Canouï-Poitrine F, Lièvre A, Dayde F, Lopez-Trabada-Ataz D, Baumgaertner I, Dubreuil O, Brunetti F, Coriat R, Maley K, Pernot S, Tournigand C, Hagege M, Aparicio T, Paillaud E, Bastuji-Garin S. Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey. Oncologist 2019; 24:e1351-e1359. [PMID: 31324663 DOI: 10.1634/theoncologist.2019-0166] [Citation(s) in RCA: 42] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2019] [Accepted: 06/21/2019] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND The primary objective was to evaluate the rates of older patients with colorectal cancer (CRC) who were eligible for a clinical trial, invited to participate, and, ultimately, included. The secondary objective was to assess the reasons for ineligibility, noninvitation, and noninclusion and factors associated. MATERIALS AND METHODS The Sujets AGés dans les Essais Cliniques (SAGE; Older Subjects in Clinical Trials) multicenter prospective cohort was established in seven centers (10 departments of medical oncology, digestive oncology, and digestive surgery) between 2012 and 2016. All patients with CRC aged 65 or older were studied. The endpoints were clinical trial availability, patient's eligibility, invitation, and enrollment in a trial. RESULTS We included 577 older patients (mean age ± SD: 75.6 ± 7 years; males: 56%; metastasis: 41%). Thirty-seven trials were ongoing (one trial for older patients). Of the 474 patients with at least one available trial for their cancer stage and site, 127 (27%) were eligible; 84 of these 127 (66%) were invited to participate, and 70 of these 84 (83%) were included. In a multivariate analysis, noninvitation was found to be associated with older age (p = .016): adjusted relative risk (95% confidence interval), 0.14 (0.02-0.60) for ≥80 vs. 65-69; 0.54 (0.18-1.04) for 75-79 vs. 65-69; 0.47 (0.17-0.93) for 70-74 vs. 65-69. CONCLUSION Three-quarters of older patients with CRC were ineligible for a clinical trial. One-third of the eligible patients were not invited to participate in a trial, and 17% of invited patients were not included. Few trials are reserved for older patients. Patients aged 80 or older were significantly less likely to be eligible for a trial and invited to participate. Clinical trial identification number: NCT01754636. IMPLICATIONS FOR PRACTICE The results of this study suggest that barriers to participation of older patients in clinical trials are particularly marked at age 80 years or older. Secondly, the results emphasize the need for trials for older patients. Thirdly, there is also a need for more pragmatic "real-world" trials, rather than solely randomized trials performed in idealized settings with strictly selected patients. Large prospective observational cohorts with a precise follow-up of toxicity, functional decline, and quality of life may constitute one way of generating more data on the risk-benefit ratio for cancer treatments in older patients.
Collapse
Affiliation(s)
- Florence Canouï-Poitrine
- Clinical Epidemiology and Ageing Unit, Institut Mondor de Recherche Biomédicale, Paris-Est University, Créteil, France
- Public Health Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| | - Astrid Lièvre
- Gastroenterology Department, CHU Pontchaillou, Rennes, France
- Rennes 1 University, Rennes, France
- Digestive Oncology Department, Institut Curie, Saint-Cloud, France
| | - Florent Dayde
- Clinical Epidemiology and Ageing Unit, Institut Mondor de Recherche Biomédicale, Paris-Est University, Créteil, France
- Clinical Research Unit (URC-Mondor), Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| | - Daniel Lopez-Trabada-Ataz
- Medical Oncology Department, Saint-Antoine Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Isabelle Baumgaertner
- Medical Oncology Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| | - Olivier Dubreuil
- Digestive Oncology Department, La Pitié-Salpetrière Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Francesco Brunetti
- Digestive Surgery Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| | - Romain Coriat
- Digestive Oncology Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Karin Maley
- Geriatric Department, Georges Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
- Geriatric Department, Les Diaconnesses, Paris, France
| | - Simon Pernot
- Digestive Oncology Department, Georges Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Christophe Tournigand
- Medical Oncology Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| | - Meoin Hagege
- Clinical Epidemiology and Ageing Unit, Institut Mondor de Recherche Biomédicale, Paris-Est University, Créteil, France
| | - Thomas Aparicio
- Digestive Oncology Department, Avicenne Hospital, Assistance Publique des Hôpitaux de Paris, Saint-Denis, France
- Digestive Oncology Department, Saint-Louis Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Elena Paillaud
- Clinical Epidemiology and Ageing Unit, Institut Mondor de Recherche Biomédicale, Paris-Est University, Créteil, France
- Geriatric Department, Georges Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
- Geriatric Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France
| | - Sylvie Bastuji-Garin
- Clinical Epidemiology and Ageing Unit, Institut Mondor de Recherche Biomédicale, Paris-Est University, Créteil, France
- Public Health Department, Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
- Clinical Research Unit (URC-Mondor), Henri-Mondor Hospital, Assistance Publique des Hôpitaux de Paris, Créteil, France
| |
Collapse
|
|
15
|
Geriatric oncology health services research: Cancer and Aging Research Group infrastructure core. J Geriatr Oncol 2019; 11:350-354. [PMID: 31326392 DOI: 10.1016/j.jgo.2019.07.012] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2019] [Revised: 07/08/2019] [Accepted: 07/09/2019] [Indexed: 02/06/2023]
|
|
16
|
Obeng-Gyasi S, Kircher SM, Lipking KP, Keele BJ, Benson AB, Wagner LI, Carlos RC. Oncology clinical trials and insurance coverage: An update in a tenuous insurance landscape. Cancer 2019; 125:3488-3493. [PMID: 31251394 DOI: 10.1002/cncr.32360] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/10/2019] [Revised: 06/04/2019] [Accepted: 06/06/2019] [Indexed: 11/07/2022]
Affiliation(s)
- Samilia Obeng-Gyasi
- Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana
| | - Sheetal M Kircher
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois
| | - Kelsey P Lipking
- Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana
| | - Benjamin J Keele
- Robert H. McKinney School of Law, Indiana University, Indianapolis, Indiana
| | - Al B Benson
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois
| | - Lynne I Wagner
- Social Sciences and Health Policy Comprehensive Cancer Center, Wake Forest School of Medicine, Winston-Salem, North Carolina
| | - Ruth C Carlos
- Department of Radiology, University of Michigan School of Medicine, Ann Arbor, Michigan
| |
Collapse
|
|
17
|
Li P, Jahnke J, Pettit AR, Wong YN, Doshi JA. Comparative Survival Associated With Use of Targeted vs Nontargeted Therapy in Medicare Patients With Metastatic Renal Cell Carcinoma. JAMA Netw Open 2019; 2:e195806. [PMID: 31199450 PMCID: PMC6575152 DOI: 10.1001/jamanetworkopen.2019.5806] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Abstract
IMPORTANCE Targeted therapies for advanced renal cell carcinoma (RCC) have shown increased tolerability and survival advantages over older treatments in clinical trials, but understanding of real-world survival improvements is still emerging. OBJECTIVE To compare overall and RCC-specific survival associated with use of targeted vs nontargeted therapy for metastatic RCC. DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study used Surveillance, Epidemiology, and End Results-Medicare data from 2000 to 2013 to examine patients with stage IV (distant) clear cell RCC at the time of diagnosis who received any targeted or nontargeted therapy. A 2-stage residual inclusion model was fitted to estimate the survival advantages of targeted treatments using an instrumental variable approach to account for both measured and unmeasured group differences. Data analyses were conducted from July 24, 2017, to April 4, 2019. EXPOSURES Targeted therapy (study group) or nontargeted therapy (control group). MAIN OUTCOMES AND MEASURES Overall survival and RCC-specific survival, defined as the interval between the date of first drug treatment and date of death or end of the observation period. RESULTS The final sample included 1015 patients (mean [SD] age, 71.2 [8.1] years; 392 [39%] women); 374 (37%) received nontargeted therapy and 641 (63%) received targeted therapy. The targeted therapy group had a greater percentage of disabled patients (ie, those <65 years old who were eligible for Medicare because of disability) and older patients (ie, those ≥75 years old) and higher comorbidity index and disability scores compared with the nontargeted therapy group. Unadjusted Kaplan-Meier survival curves showed higher overall survival for targeted vs nontargeted therapy (log-rank test, χ21 = 5.79; P = .02); median survival was not statistically significantly different (8.7 months [95% CI, 7.3-10.2 months] vs 7.2 months [95% CI, 5.8-8.8 months]; P = .14). According to the instrumental variable analysis, the median overall survival advantage was 3.0 months (95% CI, 0.7-5.3 months), and overall survival improvements associated with targeted therapy vs nontargeted therapy were statistically significant: 8% at 1 year (44% [95% CI, 39%-50%] vs 36% [95% CI, 30%-42%]; P = .01), 7% at 2 years (25% [95% CI, 20%-30%] vs 18% [95% CI, 13%-23%]; P = .009), and 5% at 3 years (15% [95% CI, 11%-19%] vs 10% [95% CI, 6%-13%]; P = .01). Receipt of targeted therapy was associated with a lower hazard of death compared with nontargeted therapy (overall survival hazard ratio, 0.78 [95% CI, 0.65-0.94]; RCC-specific survival hazard ratio, 0.77 [95% CI, 0.62-0.96]). CONCLUSIONS AND RELEVANCE Targeted therapies were associated with modest survival advantages despite a treatment group with more medical complexity, likely reflecting appropriateness for an expanded population of patients. As advances in cancer treatment continue, rigorous methods that account for unobserved confounders will be needed to evaluate their real-world impact on outcomes.
Collapse
Affiliation(s)
- Pengxiang Li
- Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
| | - Jordan Jahnke
- Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia
| | - Amy R. Pettit
- Center for Public Health Initiatives, University of Pennsylvania, Philadelphia
| | - Yu-Ning Wong
- Fox Chase Cancer Center, Philadelphia, Pennsylvania
- Now with Janssen Scientific Affairs, Titusville, New Jersey
| | - Jalpa A. Doshi
- Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
- Center for Public Health Initiatives, University of Pennsylvania, Philadelphia
| |
Collapse
|
|
18
|
Miao J, Wang L, Zhu M, Xiao W, Wu H, Di M, Huang Y, Huang S, Han F, Deng X, Guo X, Zhao C. Reprint of Long-term survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by high-total- and fractionated-dose simultaneous modulated accelerated radiotherapy with or without chemotherapy. Oral Oncol 2019; 90:126-133. [PMID: 30853080 DOI: 10.1016/j.oraloncology.2019.01.005] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
Abstract
BACKGROUND To analyse the survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by intensity-modulated radiotherapy (IMRT) with the high-total- and fractionated-dose simultaneous modulated accelerated radiation therapy (SMART) boost technique and to identify the effect of concurrent chemotherapy for these patients. METHODS Two hundred and fifty-four elderly patients (age ≥ 60.0) with newly diagnosed non-metastatic NPC were retrospectively analysed. Statistical analyses were performed using the SPSS software program. RESULTS The actual mean total and fractionated doses delivered to the gross tumour volume of the nasopharynx (GTVnx) were 74.55 Gy and 2.49 Gy, respectively. The 5-year locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), disease-specific survival (DSS) and overall survival (OS) of the whole cohort were 93.0%, 85.7%, 83.2% and 74.1%, respectively. No grade 4 acute or late radiotherapy-induced toxicities were observed. Of 247 patients with stage II-IVb disease, 89 patients received radiotherapy (RT) alone, and 158 patients received concurrent chemoradiotherapy (CCRT), and the 5-year LRRFS, DMFS, DSS and OS of the RT-alone group vs. the CCRT group were 94.0% vs. 92.2%, 83.5% vs. 86.2%, 81.8% vs. 83.1% and 74.0% vs. 72.8% (all P > 0.05), respectively. Multivariate analyses showed that CCRT was not an independent predictor for LRRFS, DMFS, DSS and OS (all P > 0.05). CONCLUSION High-total- and fractionated-dose SMART boost IMRT could obtain a satisfactory long-term outcome with mild late toxicity in elderly NPC patients. The role of CCRT needs to be further studied to optimize the treatment strategy and improve the overall survival.
Collapse
Affiliation(s)
- Jingjing Miao
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Lin Wang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Manyi Zhu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Weiwei Xiao
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Haijun Wu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Muping Di
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Yuqing Huang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Shaomin Huang
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Fei Han
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Xiaowu Deng
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Xiang Guo
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.
| | - Chong Zhao
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.
| |
Collapse
|
|
19
|
Unger JM, Hershman DL, Fleury ME, Vaidya R. Association of Patient Comorbid Conditions With Cancer Clinical Trial Participation. JAMA Oncol 2019; 5:326-333. [PMID: 30629092 PMCID: PMC6439841 DOI: 10.1001/jamaoncol.2018.5953] [Citation(s) in RCA: 110] [Impact Index Per Article: 18.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2018] [Accepted: 10/09/2018] [Indexed: 12/22/2022]
Abstract
Importance The American Society of Clinical Oncology (ASCO), Friends of Cancer Research, and the US Food and Drug Administration recently recommended modernizing criteria related to comorbidities routinely used to exclude patients from cancer clinical trials. The goal was to design clinical trial eligibility such that trial results better reflect real-world cancer patient populations, to improve clinical trial participation, and to increase patient access to new treatments in trials. Yet despite the assumed influence of comorbidities on trial participation, the relationship between patients' comorbidity profile at diagnosis and trial participation has not been explicitly examined using patient-level data. Objectives To investigate the association between comorbidities, clinical trial decision-making, and clinical trial participation; and to estimate the potential impact of reducing comorbidity exclusion criteria on trial participation, to provide a benchmark for changing criteria. Design, Setting, and Participants A national survey was embedded within a web-based cancer treatment-decision tool accessible on multiple cancer-oriented websites. Participants must have received a diagnosis of breast, lung, colorectal, or prostate cancer. In total, 5499 surveyed patients who made a treatment decision within the past 3 months were analyzed using logistic regression analysis and simulations. Exposures Cancer diagnosis and 1 or more of 18 comorbidities. Main Outcomes and Measures Patient discussion of a clinical trial with their physician (yes vs no); if a trial was discussed, the offer of trial participation (yes vs no); and, if trial participation was offered, trial participation (yes vs no). Results Of the 5499 patients who participated in the survey, 3420 (62.6%) were women and 2079 (37.8%) were men (mean [SD] age, 56.63 [10.05] years). Most patients (65.6%; n = 3610) had 1 or more comorbidities. The most common comorbid condition was hypertension (35.0%; n = 1924). Compared with the absence of comorbidities, the presence of 1 or more comorbidities was associated with a decreased risk of trial discussions (44.1% vs 37.2%; OR, 0.86; 95% CI, 0.75-0.97; P = .02), trial offers (21.7% vs 15.7%; OR, 0.82; 95% CI, 0.70-0.96; P = .02), and trial participation (11.3% vs 7.8%; OR, 0.76; 95% CI, 0.61-0.94; P = .01). The removal of the ASCO-recommended comorbidity restrictions could generate up to 6317 additional patient trial registrations every year. Conclusions and Relevance Independent of sociodemographic variables, the presence of comorbidities is adversely associated with trial discussions, trial offers, and trial participation itself. Updating trial eligibility criteria could provide an opportunity for several thousand more patients with well-managed comorbidities to participate in clinical trials each year.
Collapse
Affiliation(s)
- Joseph M. Unger
- SWOG Statistics and Data Management Center, Seattle,
Washington
- Fred Hutchinson Cancer Research Center, Seattle,
Washington
| | | | - Mark E. Fleury
- American Cancer Society Cancer Action Network Inc,
Washington, DC
| | - Riha Vaidya
- SWOG Statistics and Data Management Center, Seattle,
Washington
- Fred Hutchinson Cancer Research Center, Seattle,
Washington
| |
Collapse
|
|
20
|
Miao J, Wang L, Zhu M, Xiao W, Wu H, Di M, Huang Y, Huang S, Han F, Deng X, Guo X, Zhao C. Long-term survival and late toxicities of elderly nasopharyngeal carcinoma (NPC) patients treated by high-total- and fractionated-dose simultaneous modulated accelerated radiotherapy with or without chemotherapy. Oral Oncol 2019; 89:40-47. [PMID: 30732957 DOI: 10.1016/j.oraloncology.2018.12.008] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2018] [Revised: 12/06/2018] [Accepted: 12/11/2018] [Indexed: 10/27/2022]
Affiliation(s)
- Jingjing Miao
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Lin Wang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Manyi Zhu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Weiwei Xiao
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Haijun Wu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Muping Di
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Yuqing Huang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Shaomin Huang
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Fei Han
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Xiaowu Deng
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China
| | - Xiang Guo
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.
| | - Chong Zhao
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou 510060, China.
| |
Collapse
|
|
21
|
Clinical Outcomes of Patients With Gastrointestinal Malignancies Participating in Phase I Clinical Trials. Am J Clin Oncol 2019; 41:133-139. [PMID: 26523441 DOI: 10.1097/coc.0000000000000242] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
OBJECTIVES Early-phase clinical trials play a pivotal role in drug development. However, limited data are available on outcomes of gastrointestinal (GI) cancer patients enrolled in phase I clinical trials. Here, we evaluated the characteristics associated with survival in GI cancer patients participating in phase I clinical trials and attempted to validate previously established prognostic models. MATERIALS AND METHODS All consecutive patients with advanced GI tumors who participated in phase I clinical trials at our institution from January 2007 to December 2013 and received at least 1 dose of the study drug were included. Cox regression models were used to estimate multivariable-adjusted hazard ratio (HR) and 95% confidence interval. RESULTS In 243 study patients (median age, 62 y [range, 26 to 82 y]; 55% male), treatment included chemotherapy only (14%), targeted therapy (41%), chemotherapy+targeted therapy (42%), and others (2%) for the following disease types: pancreatic (42%), colorectal (34%), gastroesophageal (10%), hepatobiliary (13%), and others (2%). Response rate was 4%, with 38% achieving stable disease and 42% having progressive disease. Median survival was 5.8 months (range, 0.2 to 52.4 mo). Our multivariable Cox regression analyses included the following as predictors of survival: Eastern Cooperative Oncology Group performance score ≥1 (HR=1.76), prior systemic therapies ≥2 (HR=1.63), lactate dehydrogenase >618 IU/L (HR=1.85), sodium >135 mmol/L (HR=0.46), and white blood count >6×10/L (HR=1.5). Our data set was consistent with previous prognostic scores. CONCLUSIONS This is the largest study to assess clinical outcomes in this patient population. Phase I trials provide clinical benefit to patients with advanced GI malignancies and should be recommended as a treatment option in appropriate patients.
Collapse
|
|
22
|
Impact of a comprehensive geriatric assessment to manage elderly patients with locally advanced non-small–cell lung cancers: An open phase II study using concurrent cisplatin–oral vinorelbine and radiotherapy (GFPC 08-06). Lung Cancer 2018; 121:25-29. [DOI: 10.1016/j.lungcan.2018.04.017] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2018] [Revised: 04/15/2018] [Accepted: 04/19/2018] [Indexed: 12/13/2022]
|
|
23
|
Owonikoko TK, Busari AK, Kim S, Chen Z, Akintayo A, Lewis C, Carthon BC, Alese OB, El-Rayes BF, Ramalingam SS, Harvey RD. Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials. Oncology 2018; 95:138-146. [PMID: 29913438 PMCID: PMC6113074 DOI: 10.1159/000488763] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2017] [Accepted: 03/12/2018] [Indexed: 12/20/2022]
Abstract
BACKGROUND The impact of age-, gender-, and race-based differences on safety and efficacy in phase I clinical trials has not been well studied. METHODS We analyzed data from phase I clinical trials evaluating targeted biologic agents in patients with advanced solid malignancies. Race and gender distribution of enrolled patients was compared to the referral population demographics at the city, metro, and state levels. The association between age, gender, and race with type, frequency, and severity of treatment-emergent toxicities and clinical benefit was assessed using univariate and multivariable models. RESULTS Data from 117 eligible patients - Blacks/Caucasians/Others (27/85/5); male/female (66/51) - were obtained. Blacks were younger than Caucasian patients (median age of 56 vs. 62 years, p = 0.004). Nausea/vomiting was more frequent in female patients (43 vs. 24%, p = 0.03), while hematologic toxicity was more likely in Whites. While median time on treatment was comparable (113 vs. 91; p = 0.840), the median overall survival was significantly shorter for Blacks versus Caucasians (7.4 vs. 11.4 months; p = 0.0227). Black race (HR 2.11; 95% CI 1.24-3.60; p = 0.006) and older age (HR 1.03; 95% CI 1.00-1.06; p = 0.029) were associated with an increased risk of death. CONCLUSIONS Age-, gender-, and race-based disparities were observed with specific toxicity and survival outcomes on phase I clinical trials of anticancer agents.
Collapse
Affiliation(s)
- Taofeek K. Owonikoko
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
- Winship Cancer Institute of Emory University, Atlanta, GA
| | | | - Sungjin Kim
- Winship Cancer Institute of Emory University, Atlanta, GA
- Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Zhengjia Chen
- Winship Cancer Institute of Emory University, Atlanta, GA
- Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta GA, USA
| | | | - Colleen Lewis
- Winship Cancer Institute of Emory University, Atlanta, GA
| | - Bradley C. Carthon
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
| | - Olatunji B. Alese
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
| | - Bassel F. El-Rayes
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
- Winship Cancer Institute of Emory University, Atlanta, GA
| | - Suresh S. Ramalingam
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
- Winship Cancer Institute of Emory University, Atlanta, GA
| | - R. Donald Harvey
- Department of Hematology & Medical Oncology, Emory University School of Medicine, Atlanta GA
- Winship Cancer Institute of Emory University, Atlanta, GA
- Department of Pharmacology, Emory University School of Medicine, Atlanta GA
| |
Collapse
|
|
24
|
Chavez-MacGregor M, Unger JM, Moseley A, Ramsey SD, Hershman DL. Survival by Hispanic ethnicity among patients with cancer participating in SWOG clinical trials. Cancer 2018; 124:1760-1769. [PMID: 29370458 DOI: 10.1002/cncr.31241] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2017] [Revised: 11/28/2017] [Accepted: 11/30/2017] [Indexed: 12/26/2022]
Abstract
BACKGROUND Racial disparities in cancer outcomes have been described. To the authors' knowledge, it remains unclear whether patients of Hispanic ethnicity have better or worse survival outcomes. In the current study, the authors evaluated whether Hispanic participants in SWOG clinical trials had different survival outcomes compared with non-Hispanics. METHODS Adult patients registered in SWOG phase 2/3 clinical trials between 1986 and 2012 were analyzed. Studies of similar histology and stage of disease were combined. Within each analysis, Kaplan-Meier survival curves were generated to examine differences in outcome by ethnicity. Multivariate Cox regression was used to estimate the association between ethnicity and survival outcomes, controlling for major disease-specific prognostic factors and demographic variables plus area-level income and education to account for socioeconomic status. RESULTS A total of 29,338 patients registered to 38 trials were included; 5% of these patients were Hispanic. Hispanic patients were more likely to be younger and from areas of lower income and education (all P<.05). No differences in survival were observed across tumor types except in the patients with advanced stage prostate cancer, in whom the authors observed an association between Hispanic ethnicity and worse overall survival (hazard ratio [HR], 1.40; P = .006), progression-free survival (HR, 1.36; P = .007), and cancer-specific survival (HR, 1.42; P = .013). After adjusting for multiple comparisons, no differences in outcomes were noted. CONCLUSIONS Hispanic patients participating in SWOG trials who received uniform treatment and follow-up were found to have similar survival outcomes compared with non-Hispanic patients, with the single exception of those patients with advanced stage prostate cancer. The results of the current study demonstrate that Hispanic patients receiving uniform treatment and follow-up have similar outcomes compared with non-Hispanics. Cancer 2018;124:1760-9. © 2018 American Cancer Society.
Collapse
Affiliation(s)
- Mariana Chavez-MacGregor
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.,Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Joseph M Unger
- SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Anna Moseley
- SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Scott D Ramsey
- SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Dawn L Hershman
- Division of Medical Oncology, Columbia University Medical Center, New York, New York
| |
Collapse
|
|
25
|
Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, Jackson C, Taskila TK, Gardner H, Cochrane Methodology Review Group. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev 2018; 2:MR000013. [PMID: 29468635 PMCID: PMC7078793 DOI: 10.1002/14651858.mr000013.pub6] [Citation(s) in RCA: 255] [Impact Index Per Article: 36.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. OBJECTIVES To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. SEARCH METHODS We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). SELECTION CRITERIA Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. DATA COLLECTION AND ANALYSIS We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. MAIN RESULTS We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI -1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones. AUTHORS' CONCLUSIONS The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones.
Collapse
Affiliation(s)
- Shaun Treweek
- University of AberdeenHealth Services Research UnitForesterhillAberdeenUKAB25 2ZD
| | - Marie Pitkethly
- University of DundeeNRS Primary Care NetworkThe Mackenzie BuildingKirsty Semple WayDundeeTaysideUKDD2 4BF
| | - Jonathan Cook
- University of OxfordNDORMSCentre for Statistics in MedicineNuffield Orthoapedic Centre, Windmill RdOxfordScotlandUKAB25 2ZD
| | - Cynthia Fraser
- University of AberdeenHealth Services Research UnitForesterhillAberdeenUKAB25 2ZD
| | - Elizabeth Mitchell
- Hull York Medical SchoolHertford BuildingUniversity of HullHullUKHU6 7RX
| | - Frank Sullivan
- University of St AndrewsDivision of Population & Behavioural ScienceNorth HaughUniversity of St AndrewsSt AndrewsUKKY16 9TF
| | - Catherine Jackson
- University of Central LancashireHarrington BuildingHA123PrestonUKPR1 2HE
| | - Tyna K Taskila
- The Work FoundationCentre for Workforce Effectiveness21 Palmer StreetLondonUKSW1V 3PF
| | - Heidi Gardner
- University of AberdeenHealth Services Research UnitForesterhillAberdeenUKAB25 2ZD
| | | |
Collapse
|
|
26
|
Hamadeh RR, Borgan SM, Sibai AM. Cancer Research in the Arab World: A review of publications from seven countries between 2000-2013. Sultan Qaboos Univ Med J 2017; 17:e147-e154. [PMID: 28690885 DOI: 10.18295/squmj.2016.17.02.003] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2016] [Revised: 12/01/2016] [Accepted: 01/26/2017] [Indexed: 12/13/2022] Open
Abstract
This review aimed to examine trends in cancer research in the Arab world and identify existing research gaps. A search of the MEDLINE® database (National Library of Medicine, Bethesda, Maryland, USA) was undertaken for all cancer-related publications published between January 2000 and December 2013 from seven countries, including Bahrain, Kuwait, Iraq, Lebanon, Morocco, Palestine and Sudan. A total of 1,773 articles were identified, with a significant increase in yearly publications over time (P <0.005). Only 30.6% of the publications included subjects over the age of 50 years old. There was a dearth of cross-sectional/correlational studies (8.8%), randomised controlled trials (2.4%) and systematic reviews/meta-analyses (1.3%). Research exploring cancer associations mainly considered social and structural determinants of health (27.1%), followed by behavioural risk factors (14.1%), particularly tobacco use. Overall, more cancer research is needed in the Arab world, particularly analytical studies with high-quality evidence and those focusing on older age groups and associations with physical activity and diet.
Collapse
Affiliation(s)
- Randah R Hamadeh
- Department of Family & Community Medicine, College of Medicine & Medical Sciences, Arabian Gulf University, Manama, Bahrain
| | - Saif M Borgan
- Department of Pulmonary & Critical Care Medicine, University of Maryland, College Park, Maryland, USA
| | - Abla M Sibai
- Department of Epidemiology & Population Health, American University of Beirut, Beirut, Lebanon
| |
Collapse
|
|
27
|
Mackay CB, Antonelli KR, Bruinooge SS, Saint Onge JM, Ellis SD. Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate. Cancer 2017; 123:2893-2900. [DOI: 10.1002/cncr.30689] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2017] [Revised: 02/27/2017] [Accepted: 03/01/2017] [Indexed: 11/10/2022]
Affiliation(s)
- Christine B. Mackay
- Department of Health Policy and Management; University of Kansas Medical Center; Fairway Kansas
- University of Kansas Cancer Center; Fairway Kansas
| | | | | | - Jarron M. Saint Onge
- Department of Health Policy and Management; University of Kansas Medical Center; Fairway Kansas
| | - Shellie D. Ellis
- Department of Health Policy and Management; University of Kansas Medical Center; Fairway Kansas
- University of Kansas Cancer Center; Fairway Kansas
| |
Collapse
|
|
28
|
Unger JM, Cook E, Tai E, Bleyer A. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. AMERICAN SOCIETY OF CLINICAL ONCOLOGY EDUCATIONAL BOOK. AMERICAN SOCIETY OF CLINICAL ONCOLOGY. ANNUAL MEETING 2017. [PMID: 27249699 DOI: 10.14694/edbk_156686] [Citation(s) in RCA: 115] [Impact Index Per Article: 14.4] [Reference Citation Analysis] [Abstract] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
Fewer than one in 20 adult patients with cancer enroll in cancer clinical trials. Although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and they differ according to demographic and socioeconomic factors. In this article, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared with other age groups. Our analysis suggests that a clinical trial system that enrolls patients at a higher rate produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important for patients, because trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.
Collapse
Affiliation(s)
- Joseph M Unger
- From the Fred Hutchinson Cancer Research Center, Seattle, WA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centers for Disease Control and Prevention, Atlanta, GA; St. Charles Health System, Quality Department, Bend, OR
| | - Elise Cook
- From the Fred Hutchinson Cancer Research Center, Seattle, WA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centers for Disease Control and Prevention, Atlanta, GA; St. Charles Health System, Quality Department, Bend, OR
| | - Eric Tai
- From the Fred Hutchinson Cancer Research Center, Seattle, WA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centers for Disease Control and Prevention, Atlanta, GA; St. Charles Health System, Quality Department, Bend, OR
| | - Archie Bleyer
- From the Fred Hutchinson Cancer Research Center, Seattle, WA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centers for Disease Control and Prevention, Atlanta, GA; St. Charles Health System, Quality Department, Bend, OR
| |
Collapse
|
|
29
|
Subbiah IM, Wheler JJ, Hess KR, Hong DS, Naing A, Fu S, Kurzrock R, Tsimberidou AM. Outcomes of patients ≥65 years old with advanced cancer treated on phase I trials at MD ANDERSON CANCER CENTER. Int J Cancer 2017; 140:208-215. [PMID: 27599876 DOI: 10.1002/ijc.30417] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2016] [Revised: 07/05/2016] [Accepted: 07/21/2016] [Indexed: 01/19/2023]
Abstract
Patients ≥65 years with cancer remain underrepresented in clinical trials, particularly in phase I clinical trials. We analyzed the clinical course of patients ≥65 years treated on phase I clinical trials with particular emphasis on toxicities. We identified 347 consecutive patients ≥65 years with advanced cancer in our phase I clinic from 01/2004-12/2009 and analyzed disease characteristics, toxicities, survival and response. Overall, 251 patients received a targeted agent, of whom 241 (96%) received an investigational, non-FDA-approved drug. Clinical benefit (complete response + partial response + stable disease ≥ 6 months) was noted in 61 patients (18%). Eighty-nine patients (26%) had grade 3/4 toxicity, commonly hematologic, including 6 dose-limiting toxicities and 1 treatment-related death (<0.01%). Median overall survival from first Phase I Clinic visit was 8.8 months (95% CI: 7.8-10.6); median time to treatment failure was 1.9 months (95% CI: 1.8-2.1). Multivariable analyses revealed 4 indicators of lack of clinical benefit (liver metastases, performance status [PS] >1, prior radiation, ≥5 prior treatments; p <0.0001). Patients age 70-79 years had a greater risk of grade 3/4 toxicities when treated with combinations (≥2 drugs) compared to monotherapy (p = 0.006). Predictors of shorter time to treatment failure and overall survival included PS >1, thrombocytosis, >2 metastatic sites, and elevated lactate dehydrogenase (p <0.05). Our results suggest that phase I clinical trials are well tolerated in patients ≥65 years. Additionally, we identified risk factors that may facilitate patient selection for clinical trial participation.
Collapse
Affiliation(s)
- Ishwaria M Subbiah
- Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Jennifer J Wheler
- Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Kenneth R Hess
- Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX
| | - David S Hong
- Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Aung Naing
- Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX
| | - Siqing Fu
- Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX
| | | | - Apostolia M Tsimberidou
- Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX
| |
Collapse
|
|
30
|
Razenberg LGEM, van Erning FN, Pruijt HFM, Ten Tije AJ, van Riel JMGH, Creemers GJ, Lemmens VEPP. The impact of age on first-line systemic therapy in patients with metachronous metastases from colorectal cancer. J Geriatr Oncol 2016; 8:37-43. [PMID: 27659548 DOI: 10.1016/j.jgo.2016.08.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/26/2016] [Revised: 08/16/2016] [Accepted: 08/31/2016] [Indexed: 01/15/2023]
Abstract
OBJECTIVES The paucity of evidence for the optimal use of systemic therapy in elderly patients with metastatic colorectal cancer (mCRC) poses significant challenges to cancer specialists. The present population-based study provides insight into the impact of age on palliative systemic therapy in patients with metachronous metastases from CRC, in order to optimize the decision-making process. METHODS Data on the development and treatment of metachronous metastases were collected for patients with primary resected CRC diagnosed between 2003 and 2008 in the Eindhoven area of the Netherlands Cancer Registry. Patients undergoing surgery for metastases were excluded, resulting in a study population treated with palliative intent, with or without systemic therapy (n=746). RESULTS 385 patients received palliative systemic therapy (52%). Patients aged ≥75years were less likely to receive systemic therapy (31% ≥75years vs 73% <60years) and more likely to receive single-agent chemotherapy than combination-chemotherapy. Elderly patients (≥75years) treated with capecitabine-oxaliplatin (CAPOX) received fewer cycles (51% ≤3 oxaliplatin cycles, 43% ≤3 capecitabine cycles) and lower cumulative dosages compared to patients aged <75years, although initial dosages were similar. If capecitabine monotherapy (CapMono) was administered, starting dosages were 2414mg/m2/d<75years and 1992mg/m2/d≥75years (p<0.05), but no differences in number of received cycles or cumulative dosages were observed. CONCLUSION Age beginning at 75years significantly influenced palliative systemic therapy. Even in selected elderly patients, first-line treatment with CAPOX was associated with less cycles and lower cumulative dosages compared to younger patients. With single-agent fluoropyrimidine therapy, however, no such results were observed.
Collapse
Affiliation(s)
- Lieke G E M Razenberg
- Department of Internal Medicine, Catharina Hospital, Eindhoven, The Netherlands; Department of Research, Netherlands Comprehensive Cancer Organization, Eindhoven, The Netherlands.
| | - Felice N van Erning
- Department of Research, Netherlands Comprehensive Cancer Organization, Eindhoven, The Netherlands; Department of Public Health, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - Hans F M Pruijt
- Department of Internal Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands
| | - Albert J Ten Tije
- Department of Internal Medicine, Amphia Hospital, Breda, The Netherlands
| | - Johanna M G H van Riel
- Department of Internal Medicine, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands
| | - Geert-Jan Creemers
- Department of Internal Medicine, Catharina Hospital, Eindhoven, The Netherlands
| | - Valery E P P Lemmens
- Department of Research, Netherlands Comprehensive Cancer Organization, Eindhoven, The Netherlands; Department of Public Health, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| |
Collapse
|
|
31
|
Unger JM, Gralow JR, Albain KS, Ramsey SD, Hershman DL. Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. JAMA Oncol 2016; 2:137-9. [PMID: 26468994 DOI: 10.1001/jamaoncol.2015.3924] [Citation(s) in RCA: 145] [Impact Index Per Article: 16.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Affiliation(s)
- Joseph M Unger
- SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington
| | - Julie R Gralow
- Seattle Cancer Care Alliance, University of Washington, Seattle
| | - Kathy S Albain
- Loyola University, Chicago Stritch School of Medicine, Maywood, Illinois
| | - Scott D Ramsey
- University of Washington Medical Center, Seattle5Fred Hutchinson Cancer Research Center, Seattle, Washington
| | | |
Collapse
|
|
32
|
|
|
33
|
Shah A, Ricci KI, Efstathiou JA. Beyond a moonshot: insurance coverage for proton therapy. Lancet Oncol 2016; 17:559-61. [DOI: 10.1016/s1470-2045(16)00171-6] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2016] [Accepted: 03/08/2016] [Indexed: 10/21/2022]
|
|
34
|
Unger JM, Cook E, Tai E, Bleyer A. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book 2016; 35:185-98. [PMID: 27249699 PMCID: PMC5495113 DOI: 10.1200/edbk_156686] [Citation(s) in RCA: 415] [Impact Index Per Article: 46.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/05/2023]
Abstract
Fewer than one in 20 adult patients with cancer enroll in cancer clinical trials. Although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and they differ according to demographic and socioeconomic factors. In this article, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared with other age groups. Our analysis suggests that a clinical trial system that enrolls patients at a higher rate produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important for patients, because trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.
Collapse
Affiliation(s)
| | - Elise Cook
- The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Eric Tai
- Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Archie Bleyer
- St Charles Health System, Quality Department, Bend, Oregon
| |
Collapse
|
|
35
|
Wong YN, Schluchter MD, Albrecht TL, Benson AB, Buzaglo J, Collins M, Flamm AL, Fleisher L, Katz M, Kinzy TG, Liu TM, Manne S, Margevicius S, Miller DM, Miller SM, Poole D, Raivitch S, Roach N, Ross E, Meropol NJ. Financial Concerns About Participation in Clinical Trials Among Patients With Cancer. J Clin Oncol 2015; 34:479-87. [PMID: 26700120 DOI: 10.1200/jco.2015.63.2463] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
PURPOSE The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. METHODS We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): "How much of a burden on you is the cost of your medical care?," "I'm afraid that my health insurance won't pay for a clinical trial," and "I'm worried that I wouldn't be able to afford the costs of treatment on a clinical trial." Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. RESULTS One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). CONCLUSION Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients' financial needs and concerns may reduce distress and improve patient decision making.
Collapse
Affiliation(s)
- Yu-Ning Wong
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA.
| | - Mark D Schluchter
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Terrance L Albrecht
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Al Bowen Benson
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Joanne Buzaglo
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Michael Collins
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Anne Lederman Flamm
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Linda Fleisher
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Michael Katz
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Tyler G Kinzy
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Tasnuva M Liu
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Sharon Manne
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Seunghee Margevicius
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Dawn M Miller
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Suzanne M Miller
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - David Poole
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Stephanie Raivitch
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Nancy Roach
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Eric Ross
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| | - Neal J Meropol
- Yu-Ning Wong, Michael Collins, Suzanne M. Miller, Stephanie Raivitch, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania, Philadelphia, PA; Mark D. Schluchter, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller and Neal J. Meropol, Case Comprehensive Cancer Center, Case Western Reserve University; Neal J. Meropol, University Hospitals Case Medical Center, Seidman Cancer Center; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Terrance L. Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz,† International Myeloma Foundation, North Hollywood, CA; Sharon Manne, Cancer Institute of New Jersey, New Brunswick, NJ; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA
| |
Collapse
|
|
36
|
Hurria A, Levit LA, Dale W, Mohile SG, Muss HB, Fehrenbacher L, Magnuson A, Lichtman SM, Bruinooge SS, Soto-Perez-de-Celis E, Tew WP, Postow MA, Cohen HJ. Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement. J Clin Oncol 2015. [DOI: 10.1200/jco.2015.63.0319] [Citation(s) in RCA: 270] [Impact Index Per Article: 27.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors. Older adults are also the fastest growing segment of the US population. However, the evidence base for treating this population is sparse, because older adults are underrepresented in clinical trials, and trials designed specifically for older adults are rare. The result is that clinicians have less evidence on how to treat older adults, who represent the majority of patients with cancer. Clinicians and patients are forced to extrapolate from trials conducted in younger, healthier populations when developing treatment plans. This has created a dearth of knowledge regarding the risk of toxicity in the average older patient and about key end points of importance to older adults. ASCO makes five recommendations to improve evidence generation in this population: (1) Use clinical trials to improve the evidence base for treating older adults with cancer, (2) leverage research designs and infrastructure for generating evidence on older adults with cancer, (3) increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer, (4) increase clinicians' recruitment of older adults with cancer to clinical trials, and (5) use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.
Collapse
Affiliation(s)
- Arti Hurria
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Laura A. Levit
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - William Dale
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Supriya G. Mohile
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Hyman B. Muss
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Louis Fehrenbacher
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Allison Magnuson
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Stuart M. Lichtman
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Suanna S. Bruinooge
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Enrique Soto-Perez-de-Celis
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - William P. Tew
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Michael A. Postow
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| | - Harvey J. Cohen
- Arti Hurria, City of Hope, Duarte; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo, CA; Enrique Soto-Perez-de-Celis, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Laura A. Levit and Suanna S. Bruinooge, American Society of Clinical Oncology, Alexandria, VA; William Dale, University of Chicago Medical Center, Chicago, IL; Supriya G. Mohile and Allison Magnuson, University of Rochester Medical Center, Rochester; Stuart M. Lichtman, William P
| |
Collapse
|
|
37
|
Borzio M, Dionigi E, Parisi G, Raguzzi I, Sacco R. Management of hepatocellular carcinoma in the elderly. World J Hepatol 2015; 7:1521-1529. [PMID: 26085911 PMCID: PMC4462690 DOI: 10.4254/wjh.v7.i11.1521] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2014] [Revised: 03/09/2015] [Accepted: 04/10/2015] [Indexed: 02/06/2023] Open
Abstract
Mean age of hepatocellular carcinoma (HCC) patients has been progressively increasing over the last decades and ageing of these patients is becoming a real challenge in every day clinical practice. Unfortunately, international guidelines on HCC management do not address this problem exhaustively and do not provide any specific recommendation. We carried out a literature search in MEDLINE database for studies reporting on epidemiology, clinical characteristics and treatment outcome of HCC in elderly patients. Available data seem to indicate that in elderly patients the outcome of HCC is mostly influenced by liver function and tumor stage rather than by age and the latter should not influence treatment allocation. Age is not a risk for resection and older patients with resectable HCC and good liver function could gain benefit from surgery. Mild comorbidities do not seem a contraindication for surgery in aged patients. Conversely, major resection in elderly, even when performed in experienced high-volume centres, should be avoided. Both percutaneous ablation and transarterial chemoembolization are not contraindicated in aged patients and safety profile of these procedures is acceptable. Sorafenib is a viable option for advanced HCC in elderly provided that a careful evaluation of concomitant comorbidities, particularly cardiovascular ones, is taken into account. Available data seem to suggest that in either elderly and younger, treatment is a main predictor of outcome. Consequently, a nihilistic attitude of physicians towards under- or no-treatment of aged patients should not be longer justified.
Collapse
Affiliation(s)
- Mauro Borzio
- Mauro Borzio, Elena Dionigi, Ivana Raguzzi, Unità di Gastroenterologia, Azienda Ospedaliera di Melegnano, 20070 Vizzolo Predabissi, Italy
| | - Elena Dionigi
- Mauro Borzio, Elena Dionigi, Ivana Raguzzi, Unità di Gastroenterologia, Azienda Ospedaliera di Melegnano, 20070 Vizzolo Predabissi, Italy
| | - Giancarlo Parisi
- Mauro Borzio, Elena Dionigi, Ivana Raguzzi, Unità di Gastroenterologia, Azienda Ospedaliera di Melegnano, 20070 Vizzolo Predabissi, Italy
| | - Ivana Raguzzi
- Mauro Borzio, Elena Dionigi, Ivana Raguzzi, Unità di Gastroenterologia, Azienda Ospedaliera di Melegnano, 20070 Vizzolo Predabissi, Italy
| | - Rodolfo Sacco
- Mauro Borzio, Elena Dionigi, Ivana Raguzzi, Unità di Gastroenterologia, Azienda Ospedaliera di Melegnano, 20070 Vizzolo Predabissi, Italy
| |
Collapse
|
|
38
|
Mahipal A, Denson AC, Djulbegovic B, Lush R, Kumar A, Juan TH, Schell MJ, Sullivan DM. Effect of Age on Clinical Outcomes in Phase 1 Trial Participants. Cancer Control 2015; 22:235-41. [DOI: 10.1177/107327481502200217] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
Background Most persons with cancer living in the United States are older than 65 years of age; however, in general, elderly persons are under-represented in clinical trials and outcomes data are lacking. Methods Outcomes data were analyzed of elderly participants (≥ 65 years of age) enrolled in phase 1 clinical trials and the results compared with those of younger patients. All consecutive, single-center, phase 1 oncology trials initiated and completed at the H. Lee Moffitt Cancer Center & Research Institute between 1997 and 2007 were included. Patient data (including survival, response, and toxicity rates) were extracted from a cancer registry database and electronic medical records at Moffitt Cancer Center. Results After excluding multi-institution trials, we analyzed 39 trials for a total of 1,162 enrolled study participants, 32.7% of whom were elderly. Among patients who underwent transplantation, median survival rates were worse in those who were elderly compared with those who were younger (44.9 vs 32.9 months; P = .0037). However, in the no-transplantation setting, participants who were elderly had a median survival rate of 10.9 months (95% confidence interval [CI]: 8.9–13.1) compared with 8.8 months (95% CI: 7.9–10.3) in those who were younger (P = .15). Both groups had similar overall response rates (15.2% vs 13.1%) and similar treatment-related mortality rates (1% vs 0.9%, respectively). Adverse events occurring among the elderly and younger participants were not statistically significant. Conclusions Survival, response, toxicity, and treatment-related mortality rates were not significantly different between the elderly and younger phase 1 trial participants in the no-transplantation setting. Regardless of the complex pharmacological profiles and logistical issues involved in treating the elderly population, our data imply that elderly study participants do at least as well as their younger counterparts, contributing to the justification of increasing the phase 1 trial enrollment of elderly patients.
Collapse
Affiliation(s)
- Amit Mahipal
- Clinical Research Unit University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Aaron C. Denson
- Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Benjamin Djulbegovic
- Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Richard Lush
- Clinical Research Unit University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Ambuj Kumar
- Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Tzu-Hua Juan
- Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Michael J. Schell
- Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Daniel M. Sullivan
- Clinical Research Unit University of South Florida Morsani College of Medicine, Tampa, Florida
| |
Collapse
|
|
39
|
Zeng Q, Xiang YQ, Wu PH, Lv X, Qian CN, Guo X. A matched cohort study of standard chemo-radiotherapy versus radiotherapy alone in elderly nasopharyngeal carcinoma patients. PLoS One 2015; 10:e0119593. [PMID: 25768294 PMCID: PMC4359128 DOI: 10.1371/journal.pone.0119593] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2014] [Accepted: 01/29/2015] [Indexed: 11/23/2022] Open
Abstract
The impact of standard chemo-radiotherapy (CRT) as preferred therapy for elderly patients (age≥60 years) with nasopharyngeal carcinoma (NPC) remains unclear. Therefore, a strict matched cohort study was conducted to compare the survival and treatment toxicity of standard chemo-radiotherapy in the elderly NPC patients with those of radiotherapy (RT) alone. From 1998 to 2003, total 498 newly diagnosed elderly non-metastatic NPC patients were abstracted and classified into two groups by the treatments they received. For each patient in the CRT group, a matched pair in RT group was identified by matching for gender, age, histological type, T and N classifications, RT dose to primary tumor and neck nodes, and days of radiotherapy. Treatment tolerability and toxicity were clarified, and treatment outcomes were calculated and compared between the two groups. Two groups were well balanced in clinical characteristics because of the strict matching conditions. Totally 87 pairs can be assessed according to the criteria. The 5-year OS, CSS, FFS, and LR-FFS for CRT and RT groups were 62% versus 40% (P=0.013), 67% versus 47% (P=0.018), 65% versus 53% (log-rank: P=0.064, Breslow: P=0.048), and 88% versus 72%, (P=0.019), respectively. There was no significant difference in 5-year D-FFS between the two groups (75% vs. 73%, P=0.456). The CRT group experienced significantly more Grade ≥3 acute mucositis (46.0% vs. 28.7%, P= 0.019). We concluded that standard chemo-radiotherapy can achieve a reasonable local and regional control in elderly NPC patients with acceptable and reversible acute toxicity. However, distant metastasis remains the dominant failure pattern. When the elderly NPC patients are in good performance status following a complete evaluation of overall functional status and comorbidity conditions, standard chemo-radiotherapy is worthy of recommendation.
Collapse
Affiliation(s)
- Qi Zeng
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Medical Imaging & Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, China
| | - Yan-Qun Xiang
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China
| | - Pei-Hong Wu
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Medical Imaging & Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, China
| | - Xing Lv
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China
| | - Chao-Nan Qian
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China
| | - Xiang Guo
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China
- * E-mail:
| |
Collapse
|
|
40
|
Hurria A, Muss H. Special Issues in Older Women with Breast Cancer. IMPROVING OUTCOMES FOR BREAST CANCER SURVIVORS 2015; 862:23-37. [DOI: 10.1007/978-3-319-16366-6_3] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/10/2023]
|
|
41
|
Unger JM, Hershman DL, Martin D, Etzioni RB, Barlow WE, LeBlanc M, Ramsey SR. The diffusion of docetaxel in patients with metastatic prostate cancer. J Natl Cancer Inst 2014; 107:dju412. [PMID: 25540245 DOI: 10.1093/jnci/dju412] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Diffusion of new cancer treatments can be both inefficient and incomplete. The uptake of new treatments over time (diffusion) has not been well studied. We analyzed the diffusion of docetaxel in metastatic prostate cancer. METHODS We identified metastatic prostate cancer patients diagnosed from 1995 to 2007 using the Surveillance, Epidemiology, and End Results Program (SEER)-Medicare database. Medicare claims through 2008 were analyzed. We assessed cumulative incidence of docetaxel by socioeconomic, demographic, and comorbidity variables, and compared diffusion patterns to landmark events including release of phase III results and FDA approval dates. We compared docetaxel diffusion patterns in prostate cancer to those in metastatic breast, lung, ovarian, and gastric cancers. To model docetaxel use over time, we used the classic "mixed influence" deterministic diffusion model. All statistical tests were two-sided. RESULTS We identified 6561 metastatic prostate cancer patients; 1350 subsequently received chemotherapy. Among patients who received chemotherapy, docetaxel use was 95% by 2008. Docetaxel uptake was statistically significantly slower (P < .01) for patients older than 65 years, blacks, patients in lower income areas, and those who experienced poverty. Eighty percent of docetaxel diffusion occurred prior to the May, 2004 release of phase III results showing superiority of docetaxel over standard-of-care. The maximum increase in the rate of use of docetaxel occurred nearly simultaneously for prostate cancer as for all other cancers combined (in 2000). CONCLUSION Efforts to increase the diffusion of treatments with proven survival benefits among disadvantaged populations could lead to cancer population survival gains. Docetaxel diffusion mostly preceded phase III evidence for its efficacy in castration-resistant prostate cancer, and appeared to be a cancer-wide-rather than a disease-specific-phenomenon. Diffusion prior to definitive evidence indicates the prevalence of off-label chemotherapy use.
Collapse
Affiliation(s)
- Joseph M Unger
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH).
| | - Dawn L Hershman
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | - Diane Martin
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | - Ruth B Etzioni
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | - William E Barlow
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | - Michael LeBlanc
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | - Scott R Ramsey
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SRR, RBE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| |
Collapse
|
|
42
|
Accordino MK, Neugut AI, Hershman DL. Cardiac effects of anticancer therapy in the elderly. J Clin Oncol 2014; 32:2654-61. [PMID: 25071122 DOI: 10.1200/jco.2013.55.0459] [Citation(s) in RCA: 59] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
Cancer incidence increases with age, and as life expectancy increases, the number of elderly patients with cancer is increasing. Cancer treatments, including chemotherapy and radiotherapy, have significant short- and long-term effects on cardiovascular function. These cardiotoxic effects can be acute, such as changes in electrocardiogram (ECG), arrhythmias, ischemia, and pericarditis and/or myocarditis-like syndromes, or they can be chronic, such as ventricular dysfunction. Anticancer therapies can also have indirect effects, such as alterations in blood pressure, or can cause metabolic abnormalities that subsequently increase risk for cardiac events. In this review, we explore both observational and clinical trial evidence of cardiac risk in the elderly. In both observational and clinical trial data, risk of cardiotoxicity with anthracycline-based chemotherapy increases with age. However, it is less clear whether the association between age and cardiotoxicity exists for newer treatments. The association may not be well demonstrated as a result of under-representation of elderly patients in clinical trials and avoidance of these therapies in this population. In addition, we discuss strategies for surveillance and prevention of cardiotoxicity in the elderly. In the elderly, it is important to be aware of the potential for cardiotoxicity during long-term follow-up and to consider both prevention and surveillance of these late effects.
Collapse
Affiliation(s)
| | - Alfred I Neugut
- All authors: Columbia University Medical Center, New York, NY
| | - Dawn L Hershman
- All authors: Columbia University Medical Center, New York, NY.
| |
Collapse
|
|
43
|
Abstract
Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related deaths worldwide. Worldwide progressive population aging demands consensus development for decision making when treating elderly patients. Age itself might not be a critical determinant for the selection of a therapeutic option. In the past few years, the mechanisms of hepato-carcinogenesis have been elucidated, and the involvement of a number of pathways, including angiogenesis, aberrant signal transduction, and dysregulated cell cycle control, have been demonstrated, leading to evaluation of the activity and toxicity of some of the new molecularly targeted agents. Sorafenib was demonstrated to significantly increase the survival of patients with advanced HCC in two prospective, randomized, placebo-controlled trials. Subsequently, a number of retrospective or prospective studies have indicated that the effectiveness of sorafenib therapy in the treatment of HCC is similar in elderly and non-elderly patients. The aim of this review is to describe the impact of age on the effects of sorafenib-targeted therapy in patients with HCC, and the next treatment options with new targeted agents (everolimus, tivantinib, linifanib, etc.).
Collapse
|
|
44
|
Denson AC, Mahipal A. Participation of the Elderly Population in Clinical Trials: Barriers and Solutions. Cancer Control 2014; 21:209-14. [DOI: 10.1177/107327481402100305] [Citation(s) in RCA: 104] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Affiliation(s)
- Aaron C. Denson
- Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Florida
| | - Amit Mahipal
- Department of Gastrointestinal Oncology, Clinical Research Unit, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
| |
Collapse
|
|
45
|
Schiergens TS, Stielow C, Schreiber S, Hornuss C, Jauch KW, Rentsch M, Thasler WE. Liver resection in the elderly: significance of comorbidities and blood loss. J Gastrointest Surg 2014; 18:1161-70. [PMID: 24715360 DOI: 10.1007/s11605-014-2516-2] [Citation(s) in RCA: 45] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2014] [Accepted: 03/25/2014] [Indexed: 01/31/2023]
Abstract
OBJECTIVE Liver resection is increasingly performed in elderly patients who are suspected of increased postoperative morbidity (PM) and reduced overall survival (OS). Patient selection based on the identification of age-adjusted risk factors may help to decrease PM and OS. DESIGN AND PARTICIPANTS Prospectively collected data of 879 patients undergoing elective hepatic resection were analyzed. This population was stratified into three age cohorts: >70 years (n = 228; 26 %), 60-69 years (n = 309; 35 %), and <60 years (n = 342; 39 %). Multivariate survival analysis was performed. RESULTS The incidence of severe (p < 0.01) and non-surgical (p < 0.001) postoperative complications was higher in older compared to younger patients. Major estimated blood loss (EBL; p = 0.039) and comorbidities (p = 0.002) independently increased PM. EBL was comparable between all age cohorts. However, preexisting comorbidities, major EBL, and postoperative complications markedly decreased OS in contrast to younger patients. Adjusted for age, independent predictors of OS were comorbidities (HR = 1.51; p = 0.001), major hepatectomy (HR = 1.33; p = 0.025), increased EBL (HR = 1.32; p = 0.031), and postoperative complications (HR = 1.64; p < 0.001). CONCLUSION Although increased age should not be a contraindication for liver resection, this study accents the avoidance of major blood loss in elderly patients and a stringent patient selection based on preexisting comorbidities.
Collapse
Affiliation(s)
- Tobias S Schiergens
- Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, University of Munich, Campus Grosshadern, Marchioninistr. 15, 81377, Munich, Germany
| | | | | | | | | | | | | |
Collapse
|
|
46
|
Parra A, Karnad AB, Thompson IM. Hispanic accrual on randomized cancer clinical trials: a call to arms. J Clin Oncol 2014; 32:1871-3. [PMID: 24841978 DOI: 10.1200/jco.2013.51.7946] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Affiliation(s)
- Alberto Parra
- University of Texas Health Science Center at San Antonio, San Antonio, TX
| | - Anand B Karnad
- University of Texas Health Science Center at San Antonio, San Antonio, TX
| | - Ian M Thompson
- University of Texas Health Science Center at San Antonio, San Antonio, TX
| |
Collapse
|
|
47
|
Determinants of short- and long-term survival from colorectal cancer in very elderly patients. J Geriatr Oncol 2014; 5:376-83. [PMID: 24845215 DOI: 10.1016/j.jgo.2014.04.005] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2012] [Revised: 03/13/2014] [Accepted: 04/28/2014] [Indexed: 12/13/2022]
Abstract
PURPOSE Over 5100 colorectal cancers (CRCs) are diagnosed in the United Kingdom in 85 years and older age group per year but little is known of cancer progression in this group. We assessed clinical, pathological and molecular features of CRC with early and late mortality in such patients. METHODS Data were analysed in relation to early mortality and long-term survival in 90 consecutive patients with CRC aged 85 years or older in a single hospital. RESULTS Patients not undergoing operation, those with an ASA score of III or greater and those with advanced tumour stage were more likely to die within 30 days. Regression analysis showed that 30 day mortality was independently related to failure to undergo resection (odds ratio (O.R.), 10.0; 95% confidence interval [C.I.], 1.7-58.2; p=0.01) and an ASA score of III or greater (O.R. 13.0; 95% C.I., 1.4-12.6; p=0.03). All cause three and five year survival were 47% and 23% respectively for patients who are alive 30 days after diagnosis. Three and five year relative survivals were 64% and 54%, respectively. Long-term outcome was independently related to tumour stage (relative risk [R.R.], 2; 95% C.I., 1.3-3.1; p=0.001), presence of co-morbid diseases (R.R., 2.8; 95% C.I., 1.3-6.0; p=0.007) and lipid peroxidation status (R.R., 2.9; 95% C.I., 1.1-7.5; p=0.025). CONCLUSIONS An active multidisciplinary approach to the care of patients with CRC at the upper extreme of life is reasonable. It also seems sensible to individualise care based upon the extent of disease at diagnosis and the presence of co-morbid conditions. Further studies to examine the role of lipid peroxidation are warranted.
Collapse
|
|
48
|
Kelly ML, Malone D, Okun MS, Booth J, Machado AG. Barriers to investigator-initiated deep brain stimulation and device research. Neurology 2014; 82:1465-73. [PMID: 24670888 PMCID: PMC4001198 DOI: 10.1212/wnl.0000000000000345] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2013] [Accepted: 01/15/2014] [Indexed: 11/15/2022] Open
Abstract
The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients.
Collapse
Affiliation(s)
- Michael L Kelly
- From the Departments of Neurosurgery (M.L.K., A.G.M.) and Psychiatry (D.M.) and the Center for Neurological Restoration (A.G.M.), Neurological Institute, and the Center for Clinical Research (J.B.), Cleveland Clinic, OH; MacLean Center for Clinical Medical Ethics (M.L.K.), Department of Medicine, The University of Chicago, IL; and the Departments of Neurology and Neurosurgery (M.S.O.), University of Florida Center for Movement Disorders and Neurorestoration, Gainesville
| | | | | | | | | |
Collapse
|
|
49
|
Unger JM, Barlow WE, Martin DP, Ramsey SD, Leblanc M, Etzioni R, Hershman DL. Comparison of survival outcomes among cancer patients treated in and out of clinical trials. J Natl Cancer Inst 2014; 106:dju002. [PMID: 24627276 DOI: 10.1093/jnci/dju002] [Citation(s) in RCA: 184] [Impact Index Per Article: 16.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022] Open
Abstract
BACKGROUND Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, "real-world" patients with respect to presenting characteristics and survival. METHODS We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided. RESULTS We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. CONCLUSIONS Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials.
Collapse
Affiliation(s)
- Joseph M Unger
- Affiliations of authors: SWOG Statistical Center, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, WEB, ML); University of Washington, Department of Health Services Research, Seattle, WA (DPM); Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (SDR, RE); Division of Hematology/Oncology, Columbia University, New York, NY (DLH)
| | | | | | | | | | | | | |
Collapse
|
|
50
|
Gregg JR, Horn L, Davidson MA, Gilbert J. Patient enrollment onto clinical trials: the role of physician knowledge. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2014; 29:74-79. [PMID: 24163050 DOI: 10.1007/s13187-013-0548-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/02/2023]
Abstract
Sixty-six attending physicians at academic medical centers completed a 43-question self-assessment evaluating communication skills, comfort with clinical trial enrollment, and knowledge of patient-related barriers to enrollment on clinical trials. Responses and demographic information were analyzed for trends and for association with estimated trial enrollment. Physician-described enrollment of patients onto trials varied widely, with estimated enrollment varying from less than 5 patients to well over 125 enrolled during the previous year. Participants perceived themselves to have excellent communication skills and were comfortable with the trial enrollment process, though did not consistently identify patient-related barriers to enrollment. Physician knowledge of clinical trials currently enrolling within their field was associated with increased patient enrollment on study (p = 0.03). Academic physicians expressed confidence in their skills related to clinical trial enrollment despite less than ideal reported enrollment. Knowledge of clinical trials currently enrolling within a physician's specialty was associated with estimated patient enrollment, and may represent a correctable barrier to trial enrollment.
Collapse
Affiliation(s)
- Justin R Gregg
- Department of Urologic Surgery, Vanderbilt University Medical Center, A - 1302 Medical Center North, Nashville, TN, 37232-2765, USA,
| | | | | | | |
Collapse
|